Drug product
Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection 10 x 1 mL Single Dose Syringes Rx Only, Manufactured by: Gland Pharma Ltd. Hyderabad, India Manufactured for: Apotex Corp. Weston, FL 33326 NDC 60505-0795-4 UPC 360505079544 (carton) NDC 60505-0795-1 UPC (01)10360505079510 (label)
D-0261-2021
Product summary
- Firm
- Apotex Corp.
- Event
- Event 87269
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 6670 cartons
- Official record key
drug-enforcement:D-0261-2021
Official wording
Reason: Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength)
Code information: Batch: CS008 Exp. 04/2022
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling; Label Mixup